The objective of this guideline is to facilitate the compilation of a single core clinical study
report acceptable to all regulatory authorities of the ICH regions. The regulatory
authority-specific additions will consist of modules to be considered as appendices, available upon
request according to regional regulatory requirements.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.